Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 5:13 PM
Study NCT ID:
NCT01131559
Status:
TERMINATED
Last Update Posted:
2014-03-05
First Post:
2010-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'Sponsor halted study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MADRS score', 'timeFrame': '30-36 months', 'description': 'The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bipolar disorder', 'manic depression', 'depression', 'Bipolar I or II'], 'conditions': ['Bipolar', 'Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://lindnercenterofhope.org/research', 'label': 'Link to facility where study is conducted'}]}, 'descriptionModule': {'briefSummary': 'The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.\n* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.'}, 'identificationModule': {'nctId': 'NCT01131559', 'briefTitle': 'Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'Lindner Center of HOPE'}, 'officialTitle': 'Adjunctive Lisdexamfetamine in Bipolar Depression', 'orgStudyIdInfo': {'id': 'Adjunctive LDX in BP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lisdexamfetamine', 'description': 'Drug', 'interventionNames': ['Drug: Lisdexamfetamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug', 'interventionNames': ['Drug: Placebo control']}], 'interventions': [{'name': 'Lisdexamfetamine', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Oral; 20-70mg/day', 'armGroupLabels': ['Lisdexamfetamine']}, {'name': 'Placebo control', 'type': 'DRUG', 'otherNames': ['Sugar pill, fake pill with no active medication'], 'description': 'Oral; 20-70mg/day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lindner Center of HOPE', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lindner Center of HOPE', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shire', 'class': 'INDUSTRY'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}